Lupus nephritis (LN) is a type of glomerulonephritis occurring in patients with systemic lupus erythematosus (SLE). LN is a significant cause of renal failure, morbidity, and death in patients with SLE. Within 10 years of being diagnosed with SLE, 5-20% of those suffering from LN develop end-stage kidney disease, a fatal condition. Early and accurate intervention for LN is important in improving clinical outcomes.
Voclosporin, marketed as Lupkynis, is a calcineurin-inhibitor immunosuppressant for the treatment of LN. This cyclosporine A analog was approved by the FDA on January 22, 2021 following promising results in clinical trials. Early intervention with voclosporin coupled with a kidney response is believed to prevent irreversible damage to the kidney and lead to better long-term clinical outcomes for patients with LN. Voclosporin has demonstrated a more stable pharmacokinetic and pharmacodynamic relationship than cyclosporine, a higher potency than cyclosporine, and an improved metabolic profile when compared to older calcineurin inhibitors.
In July 2022, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended voclosporin be granted marketing authorization for use in combination with mycophenolate mofetil for the treatment of adult patients with active lupus nephritis.
联合免疫抑制疗法治疗成人活动性狼疮肾炎(LN)。
Labcorp Clinical Research Unit, Dallas, Texas, United States
UCLA Medical Center: Division of Rheumatology, Los Angeles, California, United States
Yale University School of Medicine: Rheumatology, Allergy & Immunology, New Haven, Connecticut, United States
Emory University School of Medicine: Division of Rheumatology, Atlanta, Georgia, United States
UNC-Chapel Hill, Chapel Hill, North Carolina, United States
Leiden University Medical Center, Leiden, Netherlands
FSGS Investigative Center, Santo Domingo, Dominican Republic
FSGS Investigative Site, Salt Lake City, Utah, United States
FSGS Investigative Centre, Santiago De Los Caballeros, Dominican Republic
AURORA Investigative Center, Oklahoma City, Oklahoma, United States
AURORA Investigative Center, Ho Chi Minh City, Vietnam
AURORA Investigative Cener, Minsk, Belarus
AURORA, Richmond, Virginia, United States
MAD VCS Site, Dasmarinas City, Cavite, Philippines
AURION Site, Kuala Lumpur, Malaysia
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